BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET

    MDR report key: 2010426 · Received March 2, 2011

    Report

    Report Number
    MW5019656
    Event Type
    Other
    Date Received
    March 2, 2011
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    LGZ
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    URGENT MEDICAL DEVICE RECALL. LOT NUMBER: 1224514, QUANTITY: 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET NONE LGZ SMITHS MEDICAL ASD, INC.
    2 LEVEL 1 NORMOTHERMIC I.V. FLUID ADMINISTRATION SET NONE FPA SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1